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EEG Biomarker Study for Participants in the Neurolief "MOOD" Trial

StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Primary completion date changed from estimate of Nov 16, 2024 to Dec 3, 2024
    • Study completion date: Nov 16, 2024 to Nov 16, 2025
    v6
  2. Minor Trial status: Enrolling by Invitation to Active, Not Recruitingv5
  3. Notable Primary and study completion dates: Nov 16, 2023 to Nov 16, 2024v4
  4. Minor 2 versions Re-verified since Jan 5, 2022, no change to tracked fieldsv2-v3
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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This study will collect EEG data at 3 time points from up to 40 adults who are enrolled in a double clinical trial investigating a device that delivers noninvasive, self-administered external Combined Occipital and Trigeminal Neurostimulation (eCOT-NS) treatment for Major Depressive Disorder (Relivion®DP). Baseline (Pre-treatment) Frontal EEG Alpha Oscillations (Power) will be compared post-stimulation power.
Trial Details
NCT Number NCT05178784
Lead Sponsor Butler Hospital
Collaborators: Neurolief Ltd., University of North Carolina, Chapel Hill
Conditions
(from sponsor)
Depression
Related terms Depression
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov